Rules and regulations - 75 fr 79296 - schedules of controlled substances: placement of 5-methoxy-n n-dimethyltryptamine into schedule i of the controlled substances act

Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Rules and Regulations
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
PART 510—NEW ANIMAL DRUGS
21 CFR Part 1308
SUPPLEMENTARY INFORMATION: Taro
Pharmaceuticals U.S.A., Inc., 3 Skyline
■ 1. The authority citation for 21 CFR [Docket No. DEA–331F]
Authority: 21 U.S.C. 321, 331, 351, 352,
Schedules of Controlled Substances:
Placement of 5-Methoxy-N,N-
Dimethyltryptamine into Schedule I of
treatment of bacterial skin infections in the Controlled Substances Act
AGENCY: Drug Enforcement
entry for ‘‘Taro Pharmaceuticals U.S.A., Inc.’’; and in the table in paragraph (c)(2) Justice. Inc.’s BACTODERM Ointment approved numerically add an entry for ‘‘051672’’ under NADA 140–839. The ANADA is ACTION: Final rule.
SUMMARY: With the issuance of this final
§ 510.600
Names, addresses, and drug
labeler codes of sponsors of approved
applications.
listed in the animal drug regulations as including its salts, isomers and salts of 051672 and a DEA review indicating that 5- This final rule will impose the criminal DATES: Effective Date: January 19, 2011.
cumulatively have a significant effect on 051672 . Taro Pharmaceuticals U.S.A., FOR FURTHER INFORMATION CONTACT:
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because PART 524—OPHTHALMIC AND
it is a rule of ‘‘particular applicability.’’ TOPICAL DOSAGE FORM NEW
SUPPLEMENTARY INFORMATION:
ANIMAL DRUGS
Background
■ 3. The authority citation for 21 CFR List of Subjects
Authority: 21 U.S.C. 360b.
§ 524.1465
[Amended]
remove ‘‘Nos. 000069 and 025463’’ and in its place add ‘‘Nos. 000069, 025463, Bernadette Dunham,
authority delegated to the Commissioner Director, Center for Veterinary Medicine. [FR Doc. 2010–31870 Filed 12–17–10; 8:45 am] BILLING CODE 4160–01–P
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Rules and Regulations
5-MeO-DMT is related to the schedule and medical evaluation and a letter categories: (1) Those concerned that the hearing period, (2) those concerned that controlled, (3) those that questioned the Secretary to consider (21 U.S.C. 811(b)). stimulus cue of 5-MeO-DMT. In in vitro serotonin 2 (5-HT2) receptors. Anecdotal Deputy Administrator of the DEA DMT. 5-MeO-DMT, however, is reported Methoxy-Dimethyltryptamine into Act’’ on August 21, 2009 (74 FR 42217), hearing period: Several commenters felt request for hearing period was too short for all interested persons to submit their request for hearing period be extended, because it is not a controlled substance, pertaining to the trafficking, distribution not posted to the electronic docket, thus period closed to obtain or prepare this and abuse of 5-MeO-DMT, according to the System to Retrieve Information from the public comment period (October 28, does not believe that a further extension analyzed by DEA laboratories comprised public had an opportunity to review all 89 grams of powder and 10 milliliters of the materials and provide comments. Comments Received
local forensic laboratories, reported 27 received in response to the first Notice scientific literature, which are available (e.g., U.S. National Library of Medicine, room admissions and a death associated contained only supporting materials for DEA (i.e., DEA’s scheduling review Support for the rule as proposed: One publications by Federal agencies (e.g., Notice of Proposed Rulemaking
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Rules and Regulations
publicly available and easily retrievable. DEA–2009–0008 (the August 21, 2009, ‘‘DMT.’’ DEA finds that this comment is and supporting materials relevant to the action as this Final Rule pertains to the 5-MeO-DMT is a naturally occurring substance: Some commenters objected DMT because 5-MeO-DMT is a naturally been provided. Prohibition or restriction of use in acknowledges the biological presence of concern that the proposed scheduling of significantly restrict the use of 5-MeO- regulatory criteria. This registration can making the findings under 21 U.S.C. 812 be obtained by submitting an application for schedule I registration in Insufficient data: Several commenters believed that insufficient data exist to concerns with respect to religion. First, addition, a commenter incorrectly stated proposed rule on the ground that the ‘‘splitting’’ of the electronic docket for from the electronic docket for the Notice postponed until more research could be commenter indicated that ‘‘splitting’’ the ‘‘extremely difficult to communicate to evaluation. Behavioral effects of 5-MeO- Employment Division v. Smith, 494 U.S. or comment on Docket No. DEA–331.’’ October 2, 2009. DEA acknowledges that receptors. In humans, 5-MeO-DMT previously in litigation, and courts have Proposed Rulemaking was separate from to DMT and other schedule I Amendment. See Olsen v. Mukasey, 541 F.3d 827 (8th Cir. 2008); O Centro emergency room admissions and a death Espirita Beneficiente Uniao do Vegetal v. Mukasey, No. 00–1647 (D. N. M. June published in the Federal Register (74
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Rules and Regulations
face of related challenges and concluded following: Regulations on or after January 19, 2011. Criminal Liability. Any activity with Thornburgh, 922 F.2d 1210 (5th Cir. instructional activities with respect to 5- 5-MeO-DMT not authorized by, or in 1991); United States v. Valazquez, 2009 WL 2823730 (W.D. Okla. Aug. 31, 2009). in such activities, must submit an application for schedule I registration in and Export Act shall be unlawful on or accordance with part 1301 of Title 21 of Regulatory Certifications
consider ‘‘providing special exemption for religious use.’’ The commenter did application for registration on or before January 19, 2011 and may continue their is a formal rulemaking ‘‘on the record after opportunity for a hearing.’’ Such Security. 5-MeO-DMT is subject to 1301.74; 1301.75(a) and (c); and 1301.76 Regulations on or after January 19, 2011. Labeling and Packaging. All labels Flexibility Act (5 U.S.C. 601–612), has of 5-MeO-DMT which are distributed on reviewed this final rule and by Scheduling of 5-MeO-DMT
Quotas. Quotas for 5-MeO-DMT must Assistant Secretary for Health, received States. This final rule will place 5-MeO- in accordance with section 201(b) of the requirements of part 1303 of Title 21 of review of the available data by DEA, and Inventory. Every registrant required to standards set forth in Sections 3(a) and on hand pursuant to §§ 1304.03, 1304.04 3(b)(2) of Executive Order 12988 Civil accepted medical use in treatment in the Records. All registrants who handle 5- responsibilities on any State; nor does it Reports. All registrants required to Unfunded Mandates Reform Act of 1995 governments, in the aggregate, or by the Regulatory Requirements
Order Forms. All registrants involved (adjusted for inflation) in any one year, sanctions applicable to the manufacture, requirements of part 1305 of Title 21 of Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Rules and Regulations
ENVIRONMENTAL PROTECTION
40 CFR Part 52
contact the person listed in the FOR
[EPA–R04–OAR–2009–0041–201058; FRL–
FURTHER INFORMATION CONTACT section to
9241–1]
rule will not result in an annual effect Office’s official hours of business are Approval and Promulgation of
more; a major increase in costs or prices: Implementation Plans; Mississippi;
Prevention of Significant Deterioration
FOR FURTHER INFORMATION CONTACT: For
Rules: Nitrogen Oxides as a Precursor
AGENCY: Environmental Protection
ACTION: Final rule.
SUMMARY: EPA is taking final action to
List of Subjects in 21 CFR Part 1308
Atlanta, Georgia 30303–8960. Telephone number: (404) 562–9352; e- (SIP), submitted by the Mississippi Department of Environmental Quality by Department of Justice regulations (28 National Ambient Air Quality Standards NAAQS, contact Ms. Jane Spann, (hereafter referred to as the ‘‘Ozone (NSR) Update’’). The Ozone Implementation NSR Update revised SUPPLEMENTARY INFORMATION:
PART 1308—SCHEDULES OF
Table of Contents
CONTROLLED SUBSTANCES
implementation of the 1997 8-hour ozone NAAQS specifically ■ 1. The authority citation for part 1308 a precursor to ozone. EPA’s approval of Mississippi’s provisions to include NO IV. Statutory and Executive Order Reviews Authority: 21 U.S.C. 811, 812, 871(b)
I. Background
■ A. Redesignating existing paragraphs parts per million—also referred to as the DATES: Effective Date: This rule will be
ADDRESSES: EPA has established a
unclassifiable for the 1997 8-hour ozone § 1308.11
Schedule I.
2009–0041. All documents in the docket implementation rule for the 1997 8-hour Web site. Although EPA’s 1997 8-hour ozone listed in the index, some information is dimethyltryptamine 7431. Some trade or not publicly available, i.e., Confidential published on April 30, 2004, and effective on June 15, 2004, provided the is not placed on the Internet and will be Michele M. Leonhart,
[FR Doc. 2010–31854 Filed 12–17–10; 8:45 am] BILLING CODE 4410–09–P
Air Planning Branch, Air, Pesticides and Rule. 70 FR 71612. The Phase II Rule Toxics Management Division, U.S.

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